Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062172) titled 'Investigation of biological tissue contained within the epidural Tuohy needle following epidural puncture for labor analgesia' on July 8.

Study Type: Observational

Primary Sponsor: Institute - Nagano Red Cross Hospital

Condition: Condition - Patients undergoing labour epidural analgesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Tissue coring can occur when an epidural Tuohy needle is inserted because it is a hollow needle. Although much less common than after spinal puncture, several cases of epidermoid cyst following epidural puncture have been reported. Tissue coring is considered a possible mechanism contributing to the development of these cysts. Epidural anaesthesia is frequently performed in young women for Caesarean delivery and labour epidural analgesia. Therefore, anaesthesiologists should be aware of rare but potentially serious long-term complications such as epidermoid cysts. The aim of this study was to determine the frequency of tissue coring during epidural puncture with a Tuohy needle and to identify the types of tissues and cells collected within the needle. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Eligibility Criteria Patients who met the inclusion criteria, did not meet any exclusion criteria, and provided written informed consent were consecutively enrolled in the study. As this was an observational study, no randomization was performed. Inclusion criteria: Women requesting labour epidural analgesia Key exclusion criteria - Exclusion criteria: Contraindications to epidural analgesia Emergency or out-of-hours cases Refusal to participate Patients considered unsuitable for the study by the investigators Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 25 Day Date of IRB - 2026 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 08 Day Last follow-up date - 2027 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067714

Disclaimer: Curated by HT Syndication.